MATERIAL SAFETY DATA SHEET

OUR MANUFACTURING FACILITIES ARE REGULARLY INSPECTED BY THE

MOST IMPORTANT NATIONAL AND INTERNATIONAL AUTHORITIES:
ITALIAN AIFA, USFDA, KFDA, PMDA, ANVISA AND ARE ALSO AUDITED
BY OUR PARTNERS AND
1. Identification of the substance/mixture and of the company/undertaking \
Identification of the substance/preparation
Product code
Product name

46034184 (TAPI/T112)
MIFEPRISTONE

Company/Undertaking Identification
TAJ ACTIVE PHARMACEUTICALS INGREDIENTS (TAPI)
UNDER LICENCE FROM: TAJ PHARMACEUTICALS LIMITED. INDIA
MANUFACTURING AT:
TAJ BELGIAN LIFE SCIENCES INDUSTRIES
DIAMANT BUILDING BOULEVARD
AUGUSTE REYERS 543 , 1030 BRUSSELS
24 hour Emergency Response:

864-536-0631

302-431-8585
Outside of the U.S. ++1-301-431-8585
For research use only. Not intended for human or animal diagnostic or therapeutic uses.
2. Hazards identification

GHS - Classification
Signal word
Danger

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Revision Date:
Product code

12-Jun-2013
46034184 (TAPI/T112)

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Product name MIFEPRISTONE
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Health hazard
Reproductive toxicity
Teratogenic

Category 1B
May cause harm to the unborn child.

Physical hazards
GHS Physical Hazard 1
GHS Physical Hazard Category Number

Flammable liquids
Category 2

Hazard statements
H225 - Highly flammable liquid and vapour
H360 - May damage fertility or the unborn child
Precautionary statements
P210 - Keep away from heat/sparks/open flames/hot surfaces. - No smoking
P243 - Take precautionary measures against static discharge
P303 + P361 + P353 - IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing. Rinse skin
with water/shower
P308 + P313 - IF exposed or concerned: Get medical advice/attention
P370 + P378 - In case of fire, use water/water spray/water jet/carbon
dioxide/sand/foam/alcohol resistant foam/chemical powder for extinction
P405 - Store locked up
Principle Routes of Exposure/
Potential Health effects
Eyes
Skin
Inhalation
Ingestion
Specific effects
Carcinogenic effects
Mutagenic effects
Reproductive toxicity
Sensitisation
Target Organ Effects

May cause eye irritation with susceptible persons.

May cause skin irritation in susceptible persons. Components of the product may
be absorbed into the body through the skin
May cause irritation of respiratory tract. Harmful by inhalation.
Harmful if swallowed.
Possible carcinogen.
none
May cause adverse reproductive effects - such as birth defect, miscarriages, or

infertility
none
Central nervous system (CNS)

Skin
Liver, kidney, and respiratory system
Heart
Eyes
Reproductive System
Blood

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Revision Date:
Product code

12-Jun-2013
46034184 (TAPI/T112)

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Product name MIFEPRISTONE
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3. Composition/information on ingredients
Chemical Name

CAS-No.
64-17-5
84371-65-3

Ethyl alcohol
RU 486

Weight percent
60-100
7-13

We recommend handling all chemicals with caution.

4. FIRST AID MEASURES

Skin contact

Rinse with plenty of water. If symptoms arise, call a physician.

Eye contact

Rinse immediately with plenty of water, also under the eyelids, for at least 15
minutes. If symptoms persist, call a physician.
Never give anything by mouth to an unconscious person. If symptoms persist, call
a physician. Do not induce vomiting without medical advice.
Move to fresh air. If symptoms persist, call a physician. If not breathing, give
artificial respiration.
Treat symptomatically.

Ingestion
Inhalation
Notes to physician

5. FIRE-FIGHTING MEASURES

Suitable extinguishing media

Water spray. Carbon dioxide (CO2). Foam. Dry chemical.

Special protective equipment for firefighters

Wear self-contained breathing apparatus and protective

suit.

6. ACCIDENTAL RELEASE MEASURES

Personal precautions

Use personal protective equipment.

Methods for cleaning up

Soak up with inert absorbent material.

Environmental precautions
Prevent further leakage or spillage if safe to do so.
See Section 12 for additional information.
7. HANDLING AND
STORAGE
Handling

Avoid contact with skin, eyes and clothing. Take precautionary measures against
static discharges.
Keep away from open flames, hot surfaces and sources of ignition. Keep in
properly labelled containers. Keep container tightly closed in a dry and
well-ventilated place.

Storage

8. Exposure controls/personal protection

Exposure limits
Chemical Name
Japan REL - Ceiling Limits
Japan OEL (TWA)
Ethyl alcohol
None
None
64-17-5
RU 486
None
None
84371-65-3
______________________________________________________________________________________________________
Revision Date:

12-Jun-2013

Product code

46034184
(TAPI/T112)

Page 3 / 6

Product name MIFEPRISTONE

www.TAJAPI.com

Engineering measures

Ensure adequate ventilation, especially in confined areas.

Personal protective equipment

Personal Protective Equipment requirements are dependent on the user institution's risk assessment and are specific
to the risk assessment for each laboratory where this material may be used.
Respiratory protection
Hand protection
Eye protection
Skin and body protection
Hygiene measures
Environmental exposure

In case of insufficient ventilation wear suitable respiratory equipment.

Impervious gloves.
Safety glasses with side-shields
Lightweight protective clothing.
Handle in accordance with good industrial hygiene and safety practice.
Prevent product from entering drains.

controls
9. PHYSICAL AND CHEMICAL PROPERTIES
General Information
Form

liquid

Appearance
Odour

No information available
No information available
C No data available
C No data available
C No data available
C No data available
No information available

Boiling Point/Range
Melting point/range
Flash point
Autoignition temperature
oxidising properties
Water solubility

F No data available
F No data available
F No data available
F No data available

No data available

10. STABILITY AND REACTIVITY

Stability

Stable under normal conditions.

Materials to avoid

Strong oxidising agents. Peroxides Acids. Acid chlorides. Acid anhydrides. Alkali
metals Ammonia
Hydrogen cyanide (hydrocyanic acid). Carbon oxides, Nitrogen Oxides. Hydrogen
chloride gas. Ammonia
Hazardous polymerisation does not occur.

Hazardous decomposition
products
polymerisation

11. TOXICOLOGICAL INFORMATION

Acute toxicity
Chemical Name
Ethyl alcohol
RU 486

LD50 (oral,rat/mouse)
7060 mg/kg Oral LD50
No data available

LD50 (dermal,rat/rabbit)
No data available
No data available

LC50 (inhalation,rat/mouse)
64,000 ppm/4hr
No data available

Principle Routes of Exposure/

Potential Health effects
Eyes
Skin
Inhalation

May cause eye irritation with susceptible persons.

May cause skin irritation in susceptible persons. Components of the product may
be absorbed into the body through the skin
May cause irritation of respiratory tract. Harmful by inhalation.

______________________________________________________________________________________________________
Revision Date:
Product code

12-Jun-2013
46034184 (TAPI/T112)

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Product name MIFEPRISTONE
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Ingestion
Carcinogenic effects

Harmful if swallowed.
Possible carcinogen.

Mutagenic effects
Reproductive toxicity

none
May cause adverse reproductive effects - such as birth defect, miscarriages, or
infertility
none
Central nervous system (CNS) Skin Liver, kidney, and respiratory system Heart

Sensitisation
Target Organ Effects

Eyes Reproductive System Blood

12. ECOLOGICAL INFORMATION

Ecotoxicity effects

No information available.

Acute aquatic toxicity

Chronic aquatic toxicity
Mobility
Biodegradation
Bioaccumulation

Not classified for acute

Not classified chronic
No information available.
No information available.
No information available

Chemical Name

Freshwater Algae
Data

Water Flea Data

Ethyl alcohol
64-17-5

Freshwater Fish
Species Data

Microtox Data

Daphnia magna
EC50=10800 mg/L (24
h) Daphnia magna
EC50=2 mg/L (48 h)
Daphnia magna
LC509268 - 14221
mg/L (48 h)

log Pow
logPow-0.32

13. DISPOSAL CONSIDERATIONS

Dispose of in accordance with local regulations.
14. TRANSPORT INFORMATION

IATA
Proper shipping name
Hazard class
Subsidiary Class
Packing group
UN-No

Ethanol Solution
3
None
II
1170
15. Regulatory information

Japan Inventories
Complies
Chemical Name
Ethyl alcohol

Japan ISHL
>0.1
Flammable substance

Japan PRTR
Not Listed

Japan PDSCL
Not listed

Japan Fire Service Law

Group 4 - Flammable liquids
II (listed under Alcohols)
Group 4 - Flammable liquids
II

RU 486
Not Listed
Not Listed
Not listed
Not listed
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Revision Date:
12-Jun-2013
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Product code

46034184
(TAPI/T112)

Product name MIFEPRISTONE

www.TAJAPI.com

Chemical Name
Ethyl alcohol

Weight percent

Japan - Air Pollution Control Law

60-100

400 - 60000

16. OTHER INFORMATION

This product formulation has been reviewed against the following Japan regulations: Fire Service Law, Poisonous and
Deleterious Substance Control Law, Pollutant Release and Transfer Register, Industrial Safety and Health Law,
Chemical Substance Control Law, Prohibition of Chemical Weapons and Regulation Specific Chemicals, Water
Pollution Control Law, Air Pollution Control Law, Narcotics and Psychotropic Control Act, Stimulants Control Act, and
Cannabis Control Act
Reason for Revision

(M)SDS sections updated

For research use only. Not intended for human or animal diagnostic or therapeutic uses.
The above information was acquired by diligent search and/or investigation and the recommendations are based on
prudent application of professional judgment. The information shall not be taken as being all inclusive and is to be used
only as a guide. All materials and mixtures may present unkown hazards and should be used with caution. Since the
Company cannot control the actual methods, volumes, or conditions of use, the Company shall not be held liable for any
damages or losses resulting from the handling or from contact with the product as described herein.

THE INFORMATION IN THIS MSDS DOES NOT CONSTITUTE A WARRENTY, EXPRESSED OR IMPLIED,
INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PUPOSE.
Copyright 2016 TAJ PHARMACEUTICALS LIMITED. INDIA License granted to make unlimited paper copies for
internal use only. The above information is believed to be correct but does not purport to be all inclusive and shall be
used only as a guide. The information in this document is based on the present state of our knowledge and is
applicable to the product with regard to appropriate safety precautions. It does not represent any guarantee of the
properties of the product. TAJ PHARMA GROUP and its Affiliates shall not be held liable for any damage resulting
from handling or from contact with the above product. See www.TAJAPI.com and/or the reverse side of invoice or
packing slip for additional terms and conditions of sale.
End of Safety Data Sheet

______________________________________________________________________________________________________
Revision Date:
Product code

12-Jun-2013
46034184 (TAPI/T112)

Page 6 / 6
Product name MIFEPRISTONE
www.TAJAPI.com